Pediatric labeling milestone

Executive Summary

FDA's approval of new labeling for Novartis' seizure therapy Trileptal addressing its use in children and teenagers marks the 100th product to add pediatric information to its label since the implementation of the FDA Modernization Act in 1997, the agency announces Dec. 19. "This is a highly gratifying achievement for our most precious patients, their parents, and their physicians," Acting FDA Commissioner Andrew von Eschenbach said. Since FDAMA was enacted, manufacturers have conducted more than 250 pediatric studies for 125 products compared to only 11 such studies in the seven years prior to the legislation. FDAMA, along with the 2002 Best Pharmaceuticals for Children Act, provide sponsors incentives for conducting pediatric trials (1"The Pink Sheet" May 14, 2001, p. 21)...